Cleared Traditional

K962017 - HYPODERMIC JET INJECTION APPARATUS

K962017 is an FDA 510(k) clearance for HYPODERMIC JET INJECTION APPARATUS, manufactured by American Jet Injector Corp.. The device is a Class 2 Dental device with product code EGM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K962017 · American Jet Injector Corp. · Dental device
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Jul 1996
Decision
64d
Days
Class 2
Risk

K962017 is an FDA 510(k) clearance for the HYPODERMIC JET INJECTION APPARATUS. Classified as Injector, Jet, Mechanical-powered (product code EGM), Class II - Special Controls.

Submitted by American Jet Injector Corp. (Lansdale, US). The FDA issued a Cleared decision on July 26, 1996 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4475 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Jet Injector Corp. devices

FDA 510(k) Submission Details - K962017

510(k) Number K962017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1996
Decision Date July 26, 1996
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGM Device Classification - Class 2, Special Controls

Product Code EGM Injector, Jet, Mechanical-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EGM Injector, Jet, Mechanical-powered

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